Biohaven .(BHVN) Prnewswire·2025-03-03 12:31Core Insights - Biohaven Ltd. has reported significant success with its investigational drug BHV-1300, a potential first-in-class IgG1,2,4 selective degrader, which has shown rapid and deep reductions in total IgG levels, indicating its potential for treating autoimmune diseases [1][3][7] Group 1: BHV-1300 Efficacy and Mechanism - In a four-week Phase 1 study, subcutaneous administration of BHV-1300 at a dose of 1000 mg weekly achieved reductions in total IgG of up to 84%, with a median reduction of 80% [2][3] - The drug selectively targets IgG1,2,4 while sparing IgG3, which is crucial for maintaining immune defense against infections [3][5] - BHV-1300 demonstrated progressive reductions in IgG levels within hours of each dose, with sustained effects over the study period [3][4] Group 2: Safety and Tolerability - BHV-1300 has been reported as safe and well-tolerated, with no clinically significant increases in liver enzymes or bilirubin, and no serious adverse events noted during the study [4][6] - Most adverse events were mild and self-resolving, with no discontinuations due to the study drug [4][6] Group 3: Future Development Plans - Based on the promising results, Biohaven plans to initiate a Phase 2 study in Graves' disease in mid-2025, with additional studies in other autoimmune diseases to follow [3][6] - The company aims to customize treatment approaches based on the depth and speed of IgG lowering achievable with BHV-1300 [3][4] Group 4: Market Context and Unmet Needs - Graves' disease affects approximately 3 million individuals in the US and 80 million globally, highlighting a significant unmet need for effective treatments that do not lead to permanent hypothyroidism or other severe side effects [6][7] - Current treatments for Graves' disease have remained unchanged for 70 years, creating an opportunity for innovative therapies like BHV-1300 to disrupt the existing treatment paradigm [6][7]